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An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OROS*-Methylphenidate
Sponsored by
Janssen-Ortho Inc., Canada
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, OROS* Methylphenidate

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past Exclusion Criteria: No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in average SNAP-IV(Swanson, Nolan and Pelham -IV) score from baseline at end of study and the remission of symptoms between groups, defined as an average SNAP-IV score of <=1 at end of study

    Secondary Outcome Measures

    changes at end of study for Parenting Stress Index, Conners Parent Rating Scale, IOWA Conners Parent Rating Scale, Visual Analogue Scale for homework and social play, Resource Use Questionnaire, parent satisfaction, Clinical Global Impression

    Full Information

    First Posted
    March 17, 2006
    Last Updated
    May 16, 2011
    Sponsor
    Janssen-Ortho Inc., Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00304681
    Brief Title
    An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
    Official Title
    The Effectiveness of CONCERTA® vs. Usual Clinical Care With Immediate Release Methylphenidate (IR MPH) in Children (6-12 Years) With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized, Open-Label Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Ortho Inc., Canada

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effectiveness and safety of OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.
    Detailed Description
    Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate release methylphenidate has limitations related to its time course of action.As the morning dose wears off, inattention may increase during late-morning classes. Similarly, when the midday dose is wearing off, the child may experience difficulty concentrating on homework. The second problem relates to compliance with midday and late afternoon dosing. Children feel stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses as a result. In other cases, a school nurse may not be available or policies prohibit staff from administering drugs so children may be required to self-administer drug. CONCERTA® was developed to overcome these limitations. The purpose of this study is to see how effective and safe Concerta* is vs. immediate release methylphenidate in children with ADHD. Patients will take either Concerta* (18, 27, 36, or 54 mg) or Immediate Release Methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder
    Keywords
    Attention Deficit Hyperactivity Disorder, OROS* Methylphenidate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    OROS*-Methylphenidate
    Primary Outcome Measure Information:
    Title
    Change in average SNAP-IV(Swanson, Nolan and Pelham -IV) score from baseline at end of study and the remission of symptoms between groups, defined as an average SNAP-IV score of <=1 at end of study
    Secondary Outcome Measure Information:
    Title
    changes at end of study for Parenting Stress Index, Conners Parent Rating Scale, IOWA Conners Parent Rating Scale, Visual Analogue Scale for homework and social play, Resource Use Questionnaire, parent satisfaction, Clinical Global Impression

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past Exclusion Criteria: No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Ortho Inc. Clinical Trial
    Organizational Affiliation
    Janssen-Ortho Inc., Canada
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16456216
    Citation
    Steele M, Weiss M, Swanson J, Wang J, Prinzo RS, Binder CE. A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder. Can J Clin Pharmacol. 2006 Winter;13(1):e50-62. Epub 2006 Jan 23.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=358&filename=CR003112_CSR.pdf
    Description
    A Randomized, Controlled, Effectiveness Trial of OROS-Methylphenidate compared to Usual Care with Immediate-Release-Methylphenidate in Attention-Deficit-Hyperactivity-Disorder

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